SOP Guide for Pharma

Job Safety Analysis for Double Cone Blender

Job Safety Analysis for Double Cone Blender

JSA for Safe Operation of Double Cone Blender

JSA Number JSA/OralDosage/009/2025 Department Oral Dosage
Revision Number V 1.0 Issue Date 01/02/2025
Effective Date 05/02/2025 Review Date 05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Double Cone Blender. This machine is widely used in the pharmaceutical industry for blending dry powders and granules uniformly to produce oral solid dosage forms. The efficient operation of the Double Cone Blender ensures the proper mixing of materials, preventing formulation inconsistencies and quality deviations.

2. Scope

This JSA applies to all operators, maintenance personnel, and supervisors involved in the operation, cleaning, and maintenance of the Double Cone Blender. Proper safety measures are essential to avoid physical injuries, contamination risks, and mechanical failures.

3. Responsibilities

Operators:

  • Follow the standard operating procedure (SOP) for the Double Cone Blender.
  • Wear appropriate Personal Protective Equipment (PPE) before starting operations.
  • Ensure materials are properly loaded into the blender.
  • Monitor machine performance and report any malfunctions.
  • Clean the blender thoroughly after each batch to prevent cross-contamination.

Supervisors:

  • Ensure strict compliance with safety protocols and monitor daily operations.
  • Conduct routine inspections and ensure all safety measures are followed.
  • Provide training to operators on safe handling and emergency procedures.

Safety Officers:

  • Conduct routine safety inspections and audits.
  • Ensure
that all operators are trained in emergency response procedures.
  • Implement risk assessment measures to reduce potential hazards.
  • 4. Definitions & Abbreviations

    • PPE: Personal Protective Equipment (e.g., gloves, goggles, respirators).
    • LOTO: Lockout/Tagout – Procedure for safely isolating hazardous energy sources.
    • Risk Assessment: Process of identifying and mitigating hazards.

    5. Procedure

    Step Task Description Potential Hazard Risk Level (L/M/H) Control Measures
    1 Machine setup and calibration Pinching, crushing injuries due to moving parts High Ensure guards are in place; follow SOP before making adjustments.
    2 Loading raw materials Ergonomic strain, dust inhalation, spillage Medium Use lifting aids; wear respiratory protection; use spill control measures.
    3 Blending operation Entanglement in rotating parts, noise exposure High Ensure hands are clear of rotating parts; use ear protection.
    4 Unloading blended material Cross-contamination, repetitive strain injury Medium Ensure proper cleaning between batches; use ergonomic lifting techniques.
    5 Cleaning and maintenance Exposure to cleaning chemicals, electrical hazards High Wear gloves and goggles; follow LOTO procedures before maintenance.

    6. Risk Assessment

    Likelihood Consequence Risk Level
    Rare Minor injuries (cuts, bruises) Low
    Possible Strain injuries due to manual handling Medium
    Likely Serious injury from mechanical failure High

    7. Emergency Procedures

    1. If an injury occurs, seek medical assistance immediately.
    2. For mechanical failures, shut down the machine and inform maintenance.
    3. In case of inhalation of powders, move to fresh air and seek medical help.
    4. All incidents must be recorded in the safety logbook.

    8. Required PPE & Safety Controls

    • Safety gloves: Prevent cuts and abrasions during operation.
    • Respiratory mask: Reduces exposure to airborne powder particles.
    • Hearing protection: Required in high-noise areas.
    • Face shield: Protects from accidental powder splashes.
    • Machine guard: Must be in place before operation.

    9. References

    • OSHA 1910.212 – Machine Guarding Standards.
    • ISO 45001 – Occupational Health & Safety Standards.
    • Manufacturer’s Operation Manual for Double Cone Blender.

    10. Approval Section

    Name Designation Signature Date
    [Name] Prepared By
    [Name] Checked By
    [Name] Approved By

    11. Revision History

    Version Date Description of Changes Approved By
    V 1.0 01/02/2025 Initial Release [Name]
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